Homeopathy Assessment in Terms of the Consumption of Analgesics After Knee Ligamentoplasty

Grenoble Alpes University Hospital Center (CHU)

Status and phase: Terminated; Phase 3

Conditions: Pain

Treatments: Drug: Bryonia alba, 5 CH; Drug: Ruta graveolens, 3 DH; Drug: Arnica montana, 5 CH; Drug: Hypericum perforatum, 5 CH

Study type: Interventional

Funder types: Other

Identifiers

NCT00222365

DCIC 03 10

Details and patient eligibility

About

This is an add-on, double blind, and randomised clinical trial with three groups: a homeopathic group, a placebo group, and a temporal control group.

The aim of this trial is to assess the effect of homeopathy on the consumption of morphine delivered by PCA (patient control analgesia) for 24 hours after a knee ligamentoplasty.

Full description

We test the effectiveness of an homeopathic drug versus placebo and a temporal control group (patient with no add-on treatment) following orthopedic knee surgery.

All patients have a PCA of morphine for 24 hours after surgery. After this period they can take an oral tablet of morphine on request.

Group A: Patients with study treatment (homeopathy) allocation. Double blind group with 70 patients

Group B: Patients with placebo allocation. Double blind group with 70 patients

Group C: Temporal control group with patients who take only the morphine. Open group with 25 patients

The total power: 70 +70 + 25 = 165 patients

Main Objective:

• To assess the effect of homeopathy in terms of morphine consumption delivered by PCA (patient control analgesia) for 24 hours after a knee ligamentoplasty.

Secondary Objectives:

• To assess the effect of homeopathy in terms of total morphine consumption between H24 and H72 after a knee ligamentoplasty.
• To assess the effect of homeopathy on the pain perception using a analogical visual scale for 72 hours.
• To asses the placebo effect of the homeopathic treatment.

Main Assessment Criterion:

• Morphine consumption delivered by PCA between 0 and 24 hours after knee ligamentoplasty

Secondary Assessment Criteria:

• Morphine consumption between 0 and 72 hours after ligamentoplasty
• Pain assessment at H0, H4, H24 and H72 using 10 cm Analogical Visual Scale

Inclusion Criteria:

• age ranging from 18 to 60.
• patients candidates for a ligamentoplasty of the anterior cruciate ligament.

Exclusion Criteria:

• patient with corticoid and immunodepressor treatment

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ranging from 18 to 60 years.
• Patients who are candidates for a ligamentoplasty of the anterior cruciate ligament.

Exclusion criteria

• Patients with corticoid and immunodepressor treatment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind